Good practices for ⁶⁸Ga radiopharmaceutical production

The radiometal gallium-68 (⁶⁸Ga) is increasingly used in diagnostic positron emission tomography (PET), with ⁶⁸Ga-labeled radiopharmaceuticals developed as potential higher-resolution imaging alternatives to traditional ^99mTc agents. In precision medicine, PET applications of ⁶⁸Ga are widespread, with ⁶⁸Ga radiolabeled to a variety of radiotracers that evaluate perfusion and organ function, and target specific biomarkers found on tumor lesions such as prostate-specific membrane antigen, somatostatin, fibroblast activation protein, bombesin, and melanocortin.

These ⁶⁸Ga radiopharmaceuticals include agents such as [⁶⁸Ga]Ga-macroaggregated albumin for myocardial perfusion evaluation, [⁶⁸Ga]Ga-PLED for assessing renal function, [⁶⁸Ga]Ga-t-butyl-HBED for assessing liver function, and [⁶⁸Ga]Ga-PSMA for tumor imaging. The short half-life, favourable nuclear decay properties, ease of radiolabeling, and convenient availability through germanium-68 (⁶⁸Ge) generators and cyclotron production routes strongly positions ⁶⁸Ga for continued growth in clinical deployment. This progress motivates the development of a set of common guidelines and standards for the ⁶⁸Ga radiopharmaceutical community, and recommendations for centers interested in establishing ⁶⁸Ga radiopharmaceutical production.

This review outlines important aspects of ⁶⁸Ga radiopharmacy, including ⁶⁸Ga production routes using a ⁶⁸Ge/⁶⁸Ga generator or medical cyclotron, standardized ⁶⁸Ga radiolabeling methods, quality control procedures for clinical ⁶⁸Ga radiopharmaceuticals, and suggested best practices for centers with established or upcoming ⁶⁸Ga radiopharmaceutical production. Finally, an outlook on ⁶⁸Ga radiopharmaceuticals is presented to highlight potential challenges and opportunities facing the community.